of raw materials, including primary packaging, to identify potential risks to product safety, authenticity, legality and quality. This shall take into account the potential for:
• allergens (allergen content and potential contamination)
• foreign-body risks
• microbiological contamination
• chemical contamination
• variety or species cross-contamination
• substitution or fraud (see clause 5.4.2)
• any risks associated with raw materials which are subject to legislative control or customer requirements.
Consideration shall also be given to the significance of a raw material to the quality of the final product.
The risk assessment shall form the basis for the raw material acceptance and testing procedure and for the processes adopted for supplier approval and monitoring.
The risk assessment for a raw material shall be updated:
• when there is a change in a raw material, the processing of a raw material, or the supplier of a raw material
• if a new risk emerges
• following a product recall or withdrawal, where a specific raw material has been implicated
• at least every 3 years.
Interpretation Raw material risk assessment
The aim of this clause is to ensure the potential risks to product safety, authenticity, legality and quality that could result from specific raw materials, have been identified, and where necessary mitigation measures put in place, for example, by adding controls into:
• supplier approval and purchasing processes
• goods receipt controls and product testing
• the food safety plan (HACCP) or specific parts of the food safety and quality management systems.
All proposed ingredients and packaging must be subjected to a documented assessment of their inherent risk.
This raw material risk assessment is not intended to be a duplication of other clauses.
For example, the reference to authenticity is not intended to duplicate the requirements within section 5.4; the processes are intended to operate together. In other words, section 5.4 should highlight any authenticity risks within the supply and identify suitable controls, whereas this clause is intended to bring those identified risks into the supplier approval, raw material management and raw material receipt processes. Similarly, this may form part of the HACCP or food safety plan; however, as this is an important starting point for the production of safe food, it needs to be detailed and will be specifically assessed by the auditor.
Interpretation
continued The assessment may be of individual products or, where a number of raw materials share the same characteristics and likely risks, these may be grouped together. When grouping materials, each should still be considered separately to ensure that it does not have different risk factors from the rest of the group. Risk, and therefore the opportunity to group ingredients or not, may vary between factories and processes because of the different overall effect on quality. For example, in a bakery, all dried fruit may be considered to be of similar risk, but where flour is a critical ingredient, it may be necessary to consider each type of flour separately (e.g. white or wholemeal); however, other non-bakery sites may group all the types of flour together.
The Standard lists the minimum types of hazards that the company must consider, including:
• allergens – both the intended allergen content and the potential for the raw material to be contaminated should be included
• foreign-body risks – these maybe intrinsic or extrinsic (i.e. an inedible part of the raw material, such as bones in animal products; or materials from the growing environment or manufacturing processes)
• microbiological contamination
• chemical contamination – including contaminants that occur naturally in the environment, those that migrate from packaging materials, or artificial additions in the supply chain (such as pesticides or veterinary medicines)
• potential for variety or species cross-contamination (i.e. where the supplier handles multiple varieties of a product and inadvertent contamination could occur during processing
• the potential for fraudulent activity in the supply chain – for example, undeclared additions, dilution or substitution of the raw material or a component of it. (As discussed above, the identification of hazards and necessary control measures may be completed as part of the activities for section 5.4.)
• the risk of non-compliance with legal requirements specific to the product (e.g. banned substances) – it is important to remember that legislative requirements in the country of raw material production may be different from those of the country where the site is located or where the final product is intended to be sold
• any customer requirements.
Identification of the actual level of risk often requires the company to consider several factors; for example:
• access to reference information and an awareness of emerging food issues are essential to ensure all known risks are assessed (clause 1.1.8)
• how the ingredient is used (e.g. an ingredient added following the final microbiological kill step may present a different risk from an ingredient added at the beginning of a process)
• nature of the supplier
• historical evidence of the supplier and raw material
• geographic origins (products from particular origins may carry a greater risk due to environmental conditions, because of more relaxed local legal requirements or a less developed food safety culture)
Part II Appendic es
Interpretation
continued • methods of manufacture/processing of the raw material (e.g. if a site is using egg as an ingredient, the microbiological risk will depend on whether fresh or pasteurised egg is used. Similarly, the type or level of processing may change the risks; for example, whole carcass, compared to cuts of meat, compared to cubes or mince or mechanically recovered meat)
• significance of the ingredient to the final product (e.g. some ‘safe’ ingredients, such as flour in breadmaking, may be fundamental to the performance of the product and therefore require higher levels of control to ensure consistent quality) and the spread of the ingredient in the company/final products
• customer or legislative requirements (e.g. suppliers may be specified by customers, but this does not negate the need for risk assessment)
• additional focus on raw materials where claims are being made about the final product (e.g. ‘organic’ or ‘suitable for allergy sufferers’) or where there is a microbiological risk from components added after heat treatment.
Sites should also consider the primary packaging materials used as they too are raw materials. There is potential for packaging materials to pose a problem, whether because of contamination, malicious intervention or the use of inappropriate materials.
Where different departments are involved in the process (e.g. head office or different sections of the site technical team), there needs to be a linked process to demonstrate the responsibilities of each team and how these work together to operate the system. The outcome of this risk assessment must also be considered when assessing the requirements for supplier approval and for monitoring and acceptance procedures (clause 3.5.1.2 and section 3.5.2).
Risk assessments must be up to date and the site must therefore review the assessment whenever there is a significant change (e.g. new suppliers, new raw materials, new countries of origin or an emerging risk) or where an incident (e.g. a product recall or withdrawal) is related to a specific raw material. At a minimum risk assessments must be reviewed every 3 years.
3.5.1.2 The company shall have a documented supplier approval procedure to ensure that all suppliers of raw materials, including primary packaging, effectively manage risks to raw material quality and safety and are operating effective traceability processes. The approval procedure shall be based on risk and include either one or a combination of:
• a valid certification to the applicable BRCGS Standard or GFSI-benchmarked standard. The scope of the certification shall include the raw materials purchased
or• supplier audits, with a scope to include product safety, traceability, HACCP review, the product security and food defence plan, the product authenticity plan and good manufacturing practices. The audit shall ensure that these plans form part of the supplier’s product safety management system and that any resultant actions are implemented.
The supplier audit shall be undertaken by an experienced and demonstrably competent product safety auditor. Where the supplier audit is completed by a second or third party, the company shall be able to:
• demonstrate the competency of the auditor
• confirm that the scope of the audit includes product safety, product security and food defence plan, product authenticity, traceability, HACCP review and good manufacturing practices
• obtain and review a copy of the full audit report
or• where a valid risk-based justification is provided and the supplier is assessed as low risk only, a completed supplier questionnaire may be used for initial approval. At a minimum, the questionnaire shall have a scope that includes product safety, product security and food defence, product authenticity, traceability, HACCP review and good manufacturing practices. The questionnaire shall have been reviewed and verified by a demonstrably competent person.
Interpretation Documented supplier approval and monitoring system
All suppliers must be evaluated for their ability to meet the specifications of the materials (ingredients and primary packaging) they are supplying and requirements for safety, quality and legality.
The company must document its procedure for supplier approval and monitoring. This needs to include the methods of approval, frequency of monitoring, responsibilities and how the process will be managed.
The acceptable methods of supplier approval will depend on the raw material and the risks associated with it (e.g. the output of clause 3.5.1.1). They will include one or more of the following activities:
• Certification to the relevant BRCGS Standard, such as the Global Standard Food Safety;
Packaging Materials; Storage and Distribution; Agents and Brokers; or another of the GFSI-benchmarked schemes. The site must confirm the validity of the certification. This will include:
• Confirmation of the certification status (e.g. this can be confirmed on an independent database; for BRCGS Standards it can be confirmed in the BRCGS Directory).
Photocopies of certificates are not recommended and on their own are not considered suitable validation of certification status. During the BRCGS audit the site may be asked to demonstrate its validation process.
Part II Appendic es
Interpretation
continued • Confirmation that the certification remains up to date (e.g. by receiving confirmation of successful completion of the recertification processes or by recording certificate expiry dates and completing checks for ongoing certification).
• Ensuring that the raw materials are within the scope of the certification. Where the product has been excluded from the scope of certification it cannot be assumed that all of the processes relating to its manufacture have been conducted in accordance with the certification requirements. For example, different facilities or equipment may be used; different raw material suppliers or risk assessment; or different staff training.
Therefore the site will need to undertake additional supplier approval processes to ensure the material is satisfactory and any risks are appropriately managed.
A successful site audit covers at a minimum product safety, traceability, HACCP, product security and the food defence plan (i.e. systems to protect the product from theft and malicious activity), product authenticity and good manufacturing processes. This audit must be completed by an appropriately experienced and competent auditor (i.e. someone who has completed training in auditing techniques, has experience of auditing, and has knowledge of the product, ingredient or processes being audited). Non-conformities should be addressed (e.g. in an agreed action plan with timescales) unless they are critical to product safety or legality, in which case supply should not be permitted until the non-conformities have been satisfactorily addressed.
When deciding the type of supplier audit to complete the company should consider the risks associated with the raw material and supplier, using this information to decide the format and duration of the audit, and whether the risk assessment indicates that some or all of the requirements can be completed remotely, or whether an entirely on-site audit is required.
If the raw material supplier is independently audited to another standard that is not GFSI- benchmarked, this may be acceptable as an alternative to the site completing its own audit of the supplier providing that:
• the scope of the audit meets the requirements of the Standard (i.e. at a minimum product safety, traceability, HACCP review, product security and food defence, food authenticity and good manufacturing practices)
• the site has a copy of the full audit report (not just a certificate)
• the supplier can demonstrate the competence of the auditor.
Where risk assessment (completed as part of this clause) indicates that a supplier is low risk (e.g. due to history of trading with the site or the nature of the raw materials traded) the completion of a supplier questionnaire with a focus on food safety and quality may be sufficient. If a supplier questionnaire is the only mechanism used to assess a supplier (i.e. there are no additional activities such as supplier audits) then it is important that the questionnaire (and replies from the ingredient supplier) contains all the relevant information to allow the site to confidently make a decision on approval.
The auditor will expect to see, and will challenge, risk assessments.
Approval and the associated risk assessments must be up to date. The site should therefore consider reviewing the assessment whenever there is a significant change (e.g. new suppliers, new countries of origin or new materials).
3.5.1.3 There shall be a documented process for ongoing supplier performance review, based on risk and defined performance criteria. The process shall be fully implemented.
Where approval is based on questionnaires, these shall be reissued at least every 3 years and suppliers shall be required to notify the site of any significant changes in the interim, including any change in certification status.
Records of the review shall be kept.
Interpretation Ongoing monitoring
Although it is important to know how and why suppliers are approved, it is also vital to ensure that ongoing approval is justified. The site is free to determine how it confers continuing approval on its suppliers, but it is important that the site uses a risk-based approach.
The defined performance criteria can be determined by the site and should depend on the supplier’s performance. However, it is important that product safety, authenticity, legality and quality are included within all supplier reviews. Therefore, while a company may wish to include other criteria (e.g. financial considerations or reliability of delivery schedules) these additional criteria must not outweigh the need to fully assess food safety, authenticity, legality and quality considerations.
As a guide, typical criteria may include:
• known risks associated with the raw material or supplier
• supplier approach to emerging concerns
• incidences of contamination or non-conforming raw materials
• quality of material supplied.
The frequency of ongoing approval is also important, and this is left to the site to determine.
However, where approval is based on supplier questionnaires, these must be reissued at least every 3 years. Good practice is to ensure that a system of proactive communication is in place, where suppliers inform the company of any changes or challenges.
The site must be able to demonstrate to an auditor that the monitoring and ongoing review it uses is appropriate, justified and risk-based.
3.5.1.4 The site shall have an up-to-date list or database of approved suppliers. This may be on paper (hard copy) or it may be controlled on an electronic system.
The list or relevant components of the database shall be readily available to the relevant staff (e.g. at goods receipt).
Interpretation Approved suppliers list
The company must also maintain an up-to-date list of approved suppliers based on the outcome of the supplier approval process. This list can either be in hard copy (i.e. paper) or electronic format (such as an approval database). It is expected that all purchased raw materials (including packaging) will be from the suppliers on the list unless it is an emergency purchase covered by clause 3.5.1.7.
The auditor may refer to the list to facilitate the effective sampling of supplier approval records.
Part II Appendic es
Interpretation
continued The list (or relevant sections of it) should be available where goods are taken in, and be accessible to anyone who needs it at the points at which it should be used. This is likely to include purchasing where this activity is carried out at the site (i.e. not at a corporate facility).
3.5.1.5 Where raw materials (including primary packaging) are purchased from companies that are not the manufacturer, packer or consolidator (e.g. purchased from an agent, broker or wholesaler), the site shall know the identity of the last manufacturer or packer, or for bulk commodity products the consolidation place of the raw material.
Information to enable the approval of the manufacturer, packer or consolidator, as in clauses 3.5.1.1 and 3.5.1.2, shall be obtained from the agent/broker or directly from the supplier, unless the agent/broker is themselves certificated to a BRCGS Standard (e.g. Global Standard Agents and Brokers) or a standard benchmarked by GFSI.
Interpretation Purchasing from agents and brokers
Potential product safety risks need to be understood for all raw materials, including those that have been purchased through an agent or broker (see glossary).
The purpose of this clause is therefore to ensure that essential information relating to traceability, product safety, authenticity, food defence, etc. is maintained and relevant details communicated, where a site has purchased a raw material from an agent or broker, or a wholesaler (i.e. not the manufacturer, packer or consolidator). The site will need sufficient information to:
• ensure traceability
• enable timely action in the event of an incident in the supply chain
• enable the approval of the last processor of the raw material, the last point of packing or the consolidation place for bulk commodity products, as described in clause 3.5.1.2.
The Standard is not prescriptive on the methods of communication used, and this
information may be provided directly by the manufacturer, processor, packer or consolidator or alternatively through the agent or broker, depending on the contractual arrangements for data handling and communication agreed between the site and the agent/broker.
For the purposes of the Standard, a place of consolidation of bulk materials is a location where a number of smaller batches are mixed to form a single bulk material (e.g. where a number of farms supply grain, which the grain merchant combines in a silo before sale, or where a cooperative arranges for a group of small growers to combine their crops for onward sale to customers). The important difference between consolidation and other types of storage or trade of materials is the mixing or combining of materials from multiple sources or batches, so that it is no longer possible to identify the individual supplier/batch for any specific portion of the bulk material (of course, for traceability purposes, it must still be possible to identify all of the suppliers/batches contributing to the bulk). Therefore, where a trader receives individually traceable units of product (e.g. sacks of material), each of which can be individually traced from supplier to customer, this does not count as a place of consolidation. The bulk material may be sold to one customer or divided and sold to multiple customers.